4-(cyclohexylamino)butane-1-sulfonic acid

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

other: Expert statement

Adequacy of study:

weight of evidence

Study period:

2020

Reliability:

2 (reliable with restrictions)

Justification for type of information:

According to conditions described in Column 2 of Section 8.5.2 of Annex VIII testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. As 4-(cyclohexylamino)butane-1-sulfonic acid is only imported as part of polymers in Europe there is no exposure scenario in which human exposure by inhalation to 4-(cyclohexylamino)butane-1-sulfonic acid particles can occur. Also 4-(cyclohexylamino)butane-1-sulfonic acid is a solid substance with a low vapor pressure (5.5 x 10-8 Pa at 25°C) exposure by inhalation of vapor is unlikely to occur. Since the criteria in Column 2 of Section 8.5.2 are not fulfilled testing by the inhalation route for 4-(cyclohexylamino)butane-1-sulfonic acid is considered not appropriate and thus testing is not performed.
See Cross references for relevant supporting data on uses, toxicological data and physical and chemical properties.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

exposure-related information

Reference

Justification for no uses reported:

other: This is a registration according to REACH Article 6(3). The substance is imported as part of polymers only and therefore identified uses are not applicable (in accordance with REACH Article 2(9)).

Justification for no exposure assessment:

substance does not meet the criteria for classification as hazardous, nor is assessed to be a PBT or vPvB, as per REACH Article 14(4) during its entire life cycle

Cross-reference 2

Reason / purpose for cross-reference:

exposure-related information

Reference

Vapour pressure at 25°C: <5.5E-8 Pa (EC A.4, OECD 104, OPPTS 830.7950: isothermal thermogravimetric effusion method)

Vapour pressure:

0 Pa

at the temperature of:

25 °C

Validation of the method was performed using a set of five reference substances.The log PT versus 1/T curve for the substance over the range 200 - 230°C showed poor linearity (correlation coefficient r < 0.99). Extrapolation of the curve to 20°C or 25°C would not give reliable results for the vapour pressure of the substance at these temperatures.

From the measured weight losses in the temperature range 200 - 230°C, the vapour pressure of the substance was determined to be lower than the vapour pressure of reference substancebenzo(ghi)perylene. The vapour pressure of the substance at 20°C and 25°C was concluded to be < 1.3E-8 Pa and < 5.5E-8 Pa, resp.

Data source

Reference

Reference Type:

other: Expert statement

Title:

Unnamed

Year:

2020

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

An expert statement was prepared

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-(cyclohexylamino)butane-1-sulfonic acid

EC Number:

629-080-0

Cas Number:

161308-34-5

Molecular formula:

C10 H21 N O3 S

IUPAC Name:

4-(cyclohexylamino)butane-1-sulfonic acid

Test material form:

solid

Details on test material:

Physical Description: White solid
Storage Conditions: At room temperature

Results and discussion

Effect levels

Key result

Remarks on result:

not measured/tested

Applicant's summary and conclusion

Conclusions:

Based on the expert statement and as the criteria in Column 2 of Section 8.5.2 of REACH are not fulfilled testing by the inhalation route is not performed.

Executive summary:

According to conditions described in Column 2 of Section 8.5.2 of Annex VIII testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. As 4-(cyclohexylamino)butane-1-sulfonic acid is only imported as part of polymers in Europe there is no exposure scenario in which human exposure by inhalation to 4-(cyclohexylamino)butane-1-sulfonic acid particles can occur. Also 4-(cyclohexylamino)butane-1-sulfonic acid is a solid substance with a low vapor pressure (5.5 x 10-8 Pa at 25°C) exposure by inhalation of vapor is unlikely to occur. Since the criteria in Column 2 of Section 8.5.2 are not fulfilled testing by the inhalation route for 4-(cyclohexylamino)butane-1-sulfonic acid is considered not appropriate and thus testing is not performed.